Evaluation of a Novel Microbiological Diagnostic Test for Latent Mycobacterium Tuberculosis Infection

NCT06728930 | Enrolling By Invitation DMC

• 1 other identifier: 59558
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) is an infectious disease that is caused by bacteria (bugs). The infection is passed on when a patient with active lung TB coughs bugs into the air, which are then breathed in by an uninfected person. In 90% of people who get infected, the TB infection remains dormant and the person never falls ill with active TB disease. However, 10% of people with dormant TB infection will eventually go on to develop active TB disease at some time in the future, with symptoms such as cough and weight loss. Dormant TB infection can be treated with a 3-month course of antibiotics, which prevent the infection from becoming active and causing problems in the future. However, existing tests for dormant TB rely on detecting the body's immune response to infection, rather than detecting the TB bugs themselves. Because the immune response doesn't go away when dormant TB is treated, existing tests for dormant TB do not change from positive to negative after antibiotic treatment. Thus, clinicians can't know if antibiotic treatment of dormant TB infection was successful or not. Moreover, existing tests can't distinguish the 90% of people with dormant TB infection who will never develop active TB (and who don't need antibiotics) from the 10% who will go on to fall ill with active TB at some point in the future (who do need antibiotics). So the investigators end up giving antibiotics to many more people than we need to. Recently, a group of scientists in Germany have developed a sensitive new blood test that was able to detect very small numbers of TB bugs in the blood of just seven people with dormant TB infection. This finding has created a lot of excitement in the TB field, as nobody has been able to find TB bugs in people with dormant infection before. Our research study will evaluate this new blood test in a larger group of 100 people, with and without dormant TB infection, to see if the findings from Germany are really true. If they are, then this could lead to the development of a more accurate test for dormant TB infection in the future.

Conditions

Latent Tuberculosis Infection; Tuberculosis Infection, Latent

Keywords

Tuberculosis; Tuberculosis Infection; Latent Tuberculosis; Latent TB; Diagnosis of latent TB; detection of TB in blood; Mtb detection in blood; TB PCR in blood

Outcome Measures

Primary Outcomes (1)

• Prevalence of Mtb DNA in blood

  Prevalence of Mtb DNA in blood of latent screenees and active TB participants

  3 years

Study Arms (2)

Latent TB screenees

Patients attending TB clinic who are being screened for latent TB. Includes recent migrants from a country with high TB prevalence, occupational health referrals with a positive IGRA, household contacts of TB cases and patients who are about to start biological therapy (eg. anti-TNF)

Active TB patients

Patients with active TB who are not already on anti-tuberculous treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Two groups of participants will be recruited: adults being screened for LTBI (LTBI screenees), and patients about to initiate treatment for active TB (active cases). LTBI screenees are those who are being screened for LTBI as part of standard care: they include recent contacts of an infectious index TB case, new entrants from high TB burden countries, health workers undergoing occupational health screening and patients who are about to undergo immunosuppressive therapy. Patients with active TB are those who have been diagnosed with active TB who are about to start taking anti-TB therapy.

You may qualify if:

• Age ≥16 years
• Undergoing screening for LTBI
• Gives written informed consent to participate

You may not qualify if:

• Known HIV infection
• Declines HIV testing
• Previous antimicrobial treatment for active TB or latent TB infection
• Clinical suspicion of active TB
• Already initiated chemoprophylaxis
• Age ≥16 years
• Newly-diagnosed active TB about to initiate treatment
• Gives written informed consent to participate
• Known HIV infection
• Declines HIV testing
• Already initiated anti-TB treatment
• Haemoglobin concentration \<10 g/dl at screening

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Blizard Institute, Queen Mary University London

London, E1 2AT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cryopreserved PBMC and heat treated PBMC and lysed cell samples

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: December 11, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

GB (1)